Trodat 1 SPECT and Dopamine Polymorphism

Association of Polymorphism in Genes Associated With Control of Dopamine Levels in Parkinson's Disease and Tc-99m-Trodat-1 SPECT Imaging.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01381302

Enrollment

Registered

2011-06-27

Start date

2011-08-31

Completion date

2012-08-31

Last updated

2016-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

Keywords

Severity of disease

Brief summary

The study population will include 100 parkinsonian patients in early stage of disease, with total duration not exeeding 5 years. The patients will undergo neurologic examination and evaluation of disease severity using the unified PD rating scale. Subsequently a brain SPECT will be performed using Tc-99m-Trodat1.

Detailed description

The study sample will include 100 Israeli Jewish patients with early idiopathic PD who were not treated with anti-parkinson drugs. The clinical diagnosis will be based on the criteria of the United Kingdom Parkinson Disease Society Brain Bank.5 All patients will undergo Tc-99m-Trodat1 SPECT. The severity of the motor symptoms will be assessed with the Unified PD Rating Scale (UPDRS). Genomic DNA is extracted from peripheral blood leukocytes for genetic analysis.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

35 Years to 80 Years

Healthy volunteers

Inclusion criteria

Inclusion criteria were 1. early Israeli PD patients 2. Of jewish origin, males or females 3. Undergoing DAT-scan examination in Wolfson medical center at early stage of disease, accompanied by a UPDRS evaluation at that stage,performed by a trained neurologist 4. Patients did not use any type of anti-parkinsonian drug type, at time of DAT-scan performance and UPDRS evaluation 5. DNA sample was obtained 6. Patients were able to sign an informed consent form to participate in this study.

Exclusion criteria

* Patients were excluded if they features secondary parkinsonism or if they were treated with medications that block dopamine receptors.

Design outcomes

Primary

Measure	Time frame	Description
Disease severity versus genetic polymorphism	1 year	Correlation of disease severity with polymorphism and with striatal affinity to the DAT ligand.

Secondary

Measure	Time frame	Description
Severity of PD compared to specific striatal DAT activity as measures by Tc-99m Trodat SPECT.	1 year	For each striatal ROI, mean counts will be measured, and specific TRODAT uptake will be calculated, according to the following formula: Specific TRODAT uptake = (mean activity in ROI - mean Activity in occipital cortex) / mean Activity in occipital cortex).

Countries

Israel

Outcome results